Sheathless guide, rapid exchange dilator and associated methods

ABSTRACT

Dilators, such as rapid exchange dilators, configured for percutaneous access are disclosed. The dilator may be configured to be disposable within, or couplable with, a catheter. In some embodiments, the dilator, or the coupled dilator and the catheter, may be configured such that a sheath is not required for percutaneous access. In other embodiments, the dilator may comprise a plug such that a guide wire may be directed from a distal end of the dilator through a port, such as a rapid exchange port, in a sidewall of the dilator. The plug may also be configured to permit passage of fluid through a lumen of the dilator while inhibiting passage of the guide wire through a length of the dilator.

TECHNICAL FIELD

This application claims priority to U.S. Provisional Application No.61/870,082, filed on Aug. 26, 2013 and titled “Rapid Exchange Dilatorand Associated Methods,” which is hereby incorporated by reference inits entirety.

TECHNICAL FIELD

The present disclosure relates generally to dilators configured forpercutaneous access. The disclosed dilators may also be disposable in,and/or couplable with, catheters for use during vascular procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments disclosed herein will become more fully apparent fromthe following description and appended claims, taken in conjunction withthe accompanying drawings. These drawings depict only typicalembodiments, which will be described with additional specificity anddetail through use of the accompanying drawings in which:

FIG. 1 is a perspective view of a first embodiment of a dilator.

FIG. 2A is a perspective view of a distal portion of the dilator of FIG.1.

FIG. 2B is a top view of the distal portion of the dilator of FIG. 1.

FIG. 2C is a cross-sectional view of the portion of the dilator of FIG.2B taken through line 2C-2C.

FIG. 2D is a cross-sectional view of the portion of the dilator of FIG.2C taken through line 2D-2D.

FIG. 3A is a perspective view of a distal portion of a second embodimentof a dilator.

FIG. 3B is a top view of the portion of the dilator of FIG. 3A.

FIG. 3C is a cross-sectional view of the portion of the dilator of FIG.3B taken through line 3C-3C.

FIG. 3D is a cross-sectional view of the portion of the dilator of FIG.3C taken through line 3D-3D.

FIG. 4A is a perspective view of a distal portion of a third embodimentof a dilator.

FIG. 4B is a top view of the portion of the dilator of FIG. 4A.

FIG. 4C is a cross-sectional view of the portion of the dilator of FIG.4B taken through line 4C-4C.

FIG. 4D is a cross-sectional view of the portion of the dilator of FIG.4C taken through line 4D-4D.

FIG. 5A is a perspective view of a distal portion of a fourth embodimentof a dilator.

FIG. 5B is a top view of the portion of the dilator of FIG. 5A.

FIG. 5C is a cross-sectional view of the portion of the dilator of FIG.5B taken through line 5C-5C.

FIG. 5D is a cross-sectional view of the portion of the dilator of FIG.5C taken through line 5D-5D.

FIG. 6A is a perspective view of a distal portion of a fifth embodimentof a dilator.

FIG. 6B is a top view of the portion of the dilator of FIG. 6A.

FIG. 6C is a cross-sectional view of the portion of the dilator of FIG.6B taken through line 6C-6C.

FIG. 6D is a cross-sectional view of the portion of the dilator of FIG.6C taken through line 6D-6D.

FIG. 7A is a perspective view of a distal portion of a sixth embodimentof a dilator.

FIG. 7B is a top view of the portion of the dilator of FIG. 7A.

FIG. 7C is a cross-sectional view of the portion of the dilator of FIG.7B taken through line 7C-7C.

FIG. 7D is a cross-sectional view of the portion of the dilator of FIG.7C taken through line 7D-7D.

FIG. 8 is a perspective view of an embodiment of a vascular accesssystem.

FIG. 9 is a perspective view of a portion of the vascular access systemof FIG. 8.

FIG. 10A is a view showing introduction of a needle into a vessel.

FIG. 10B is a view showing introduction of a first guide wire into thevessel through a lumen of the needle.

FIG. 100 is a view showing removal of the needle from the vessel.

FIG. 10D is a view showing threading of a proximal end of the firstguide wire through a distal end of a dilator wherein the dilator isdisposed within a catheter.

FIG. 10E is a view showing disposition of the dilator and the catheterin the vessel.

FIG. 10F is a view showing removal of the first guide wire from thevessel.

FIG. 10G is a view showing removal of the dilator from the vessel.

FIG. 10H is a view showing disposition of a second guide wire throughthe catheter.

FIG. 10I is a view showing disposition and visualization of thedisposition of a distal end of the catheter at a therapy site.

FIG. 10J is a view showing performance and visualization of theperformance of a vascular procedure at the therapy site.

FIG. 10K is a view showing removal of the catheter from the vessel.

DETAILED DESCRIPTION

A dilator may be configured for percutaneous access. Percutaneous accessmay be made at an artery, such as the brachial artery, femoral artery,radial artery, carotid artery; a vein such as the jugular vein; oranother physiological feature, including other locations of thevasculature. The dilator may be configured to be disposable within, orcouplable with, a catheter. In some embodiments, the dilator, or thecoupled dilator and catheter, may be configured such that a sheath isnot utilized during percutaneous access. Percutaneous access may allowintroduction of a medical device into a vessel of a patient anddisposition of the medical device at or adjacent a therapy site withinthe vessel. Introduction of a medical device into a vessel may be usedfor performance a vascular procedure. Medical devices that may beintroduced into a vessel include, but are not limited to, atherectomydevices (i.e., rotobladers), aspirators, balloon catheters, diagnosticcatheters, guiding catheters, interventional catheters, snares, andstents.

It will be readily understood by one of skill in the art having thebenefit of this disclosure that the components of the embodiments, asgenerally described and illustrated in the figures herein, could bearranged and designed in a variety of configurations. Thus, thefollowing more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thedisclosure, but is merely representative of various embodiments. Whilethe various aspects of the embodiments are presented in drawings, thedrawings are not necessarily drawn to scale unless specificallyindicated.

The phrases “connected to,” “coupled to,” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be coupled to each other even thoughthey are not in direct contact with each other. For example, twocomponents may be coupled to each other through an intermediatecomponent.

As used herein, the term “dilator” refers to an elongate medical deviceconfigured to expand or enlarge an opening in a vessel as the dilator isadvanced through the opening. Therefore, in some embodiments, a dilatormay comprise a taper at a first end. In certain embodiments, a dilatormay be utilized in combination with a catheter and/or sheath. A dilatormay also be stiffer than a catheter and/or sheath. A relatively stiffdilator may be configured to facilitate advancement of a relativelyflexible catheter through the wall of a body lumen. Still further, atapered dilator may be configured to provide a smooth transition betweenthe outside diameter of a guide wire and the outside diameter of acatheter (and/or sheath) as the dilator and catheter (and/or sheath) isadvanced along the guide wire into a body lumen.

The terms “proximal” and “distal” refer to opposite ends of a medicaldevice. With respect to dilators and vascular access systems disclosedherein, the proximal end refers to the end nearest a practitioner whenthe device is in use.

FIG. 1 is perspective view of a first embodiment of a dilator 100, whichmay be configured as a rapid exchange dilator. In some embodiments, thedilator 100 may be flexible, plastic, and/or pliable. In the illustratedembodiment, the dilator 100 comprises an elongate member 102, whereinthe elongate member 102 comprises both a proximal end 104 and a distalend 106. In some embodiments, the dilator 100 may comprise a lumen 108disposed within at least a portion of the elongate member 102. Theillustrated dilator 100 further comprises a port 110, which may beconfigured as a rapid exchange port, disposed in a sidewall of theelongate member 102, wherein the port 110 may be in fluid communicationwith the lumen 108. As illustrated, the port 110 is elongate. In otherembodiments, the port 110 may be circular, rectangular, square,triangular, or otherwise shaped. Ports 110 of any size and/or shape arewithin the scope of this disclosure. In other embodiments, there may bemore than one port 110, for example, there may be two ports, threeports, four ports, and so on. In some embodiments, the lumen 108 mayextend from the proximal end 104 to the distal end 106 of the elongatemember 102, or the lumen 108 may extend through only a portion of theelongate member 102. In other embodiments, there may be more than onelumen 108, for example, there may be two lumens, three lumens, fourlumens, and so on.

In some embodiments, at least a portion of the dilator 100 may beradiopaque. For example, the dilator 100 may comprise one or moreradiopaque bands 124. The radiopaque bands 124 may assist a practitionerin determining and/or visualizing the location or position of thedilator 100 within a patient. For example, the practitioner may use afluoroscope, or other imaging device, to visualize the location of thedilator 100 within the vasculature of the patient by locating thepositions of the radiopaque bands 124. In some embodiments, theradiopaque bands 124 may be positioned at predetermined points along alength of the dilator 100. For example, a radiopaque band 124 may bepositioned at or adjacent to the distal end 106 of the dilator 100 asillustrated in FIG. 1.

Also, the distal end 106 of the illustrated dilator 100 is tapered.Other configurations of the dilator 100, however, such as a dilatorlacking a tapered end or a dilator comprising a longer or shortertapered portion, are also within the scope of this disclosure. In someembodiments, at least a portion of the dilator 100 may be hydrophilic orotherwise lubricious. For example, a portion of an outside surface ofthe dilator 100 may be hydrophilic such that the outside surface of thedilator 100 is lubricious, slippery, and/or smooth such that the dilator100 may be disposed or moved through a percutaneous access site and/or atortuous and/or narrow vascular anatomy.

In some embodiments, a portion of an outside surface of the dilator 100,extending from a proximal end 111 of the port 110, may comprise a recessconfigured to accommodate a portion of a guide wire. Such aconfiguration may aid in disposition or movement of the dilator 100 incombination with a guide wire through a percutaneous access site and/orthrough a patient's vasculature.

An apparatus for a percutaneous access site is also within the scope ofthis disclosure. The apparatus may comprise an elongate member, likeelongate member 102, configured for passage of a fluid or fluids throughat least a portion of the elongate member. The elongate member may befurther configured for passage of a guide wire through only a portion ofthe elongate member. In other embodiments, the elongate member may beconfigured for passage of a fluid or fluids along substantially anentire length of the elongate member. In some embodiments, the guidewire may be displaceable along a portion of the elongate member througha first opening of the elongate member and the elongate member may beconfigured to direct the guide wire out of a second opening of theelongate member. For example, the elongate member may comprise an angledguiding surface configured to direct the guide wire out of the secondopening of the elongate member. In certain embodiments, the secondopening may be disposed in a sidewall of the elongate member.

FIGS. 2A-2D are various views of a distal portion of the dilator 100 ofFIG. 1. FIG. 2A is a perspective view of the distal portion of thedilator 100 of FIG. 1. FIG. 2B is a top view of the distal portion ofthe dilator 100 of FIG. 1; FIG. 2C is a cross-sectional view of theportion of the dilator 100 of FIG. 2B taken through line 2C-2C; and FIG.2D is a cross-sectional view of the portion of the dilator 100 of FIG.2C taken through line 2D-2D. As illustrated in FIGS. 2A-2D, the dilator100 may further comprise a plug 114 disposed in the lumen 108, proximalto at least a portion of the port 110. In some embodiments, the plug 114may be disposed at a position more proximal to the port 110 than isillustrated. While in other embodiments, a distal end 116 of the plug114 may be disposed at a position more distal to a proximal end 111 ofthe port 110 than is illustrated.

In the illustrated embodiment of FIG. 2D, the distal end 116 of the plug114 defines an angled surface 118 extending from a surface of the lumen108 opposite of the port 110 to a position at or adjacent a proximal end111 of the port 110. Stated another way, the distal end 116 of the plug114 may be wedge-shaped. In other embodiments, the distal end 116 of theplug 114 may comprise a concave curve or a convex curve. Otherconfigurations of the distal end 116 of the plug 114 are also within thescope of this disclosure. The angled surface 118 may be configured todirect a guide wire or other medical device advanced through an opening101 at the distal end 106 of the elongate member 102 through the port110. The angled surface 118 may be configured such that the guide wireor other medical device does not get caught or stuck at a junctionbetween the plug 114 and the elongate member 102. In some embodiments,the angled surface 118 may be configured such that the guide wire or theother medical device makes a smooth transition as it moves from aninterior of the dilator to an exterior of the dilator 100. In someembodiments, the guide wire or other medical device may be introduced orthreaded into the dilator 100 through the port 110, into the lumen 108of the elongate member 102, and out the opening 101 at the distal end106 of the dilator 100. In such an embodiment, the angled surface 118may also be configured such that the guide wire or other medical devicesmoothly transitions as it moves or is displaced from the exterior ofthe dilator 100 to the interior of the dilator 100.

The plug 114, as illustrated in FIG. 2D, is configured such that itoccludes the lumen 108. In such a configuration, the dilator 100 may beconfigured such that fluid communication through the lumen 108 betweenthe proximal end and the distal end 106 of the elongate member 102 isblocked, inhibited, or substantially inhibited at the plug 114.

In other embodiments, the lumen 108 may extend from the distal end 106of the elongate member 102 to the port 110. In such embodiments, aportion of the elongate member 102 proximal to the lumen 108 may besolid. The lumen 108 may also be configured to direct a guide wireextending from the distal end 106 of the elongate member 102 through theport 110.

In certain embodiments, the plug 114 may be coupled to the elongatemember 102. For example, the plug 114 may be bonded or glued to theelongate member 102. In other embodiments, the plug 114 may beintegrally formed with the elongate member 102. For example, the plug114 may be extruded and/or molded as an integral or intrinsic part ofthe elongate member 102.

FIGS. 3A-3D are various views of a distal portion of a second embodimentof a dilator 200. FIG. 3A is a perspective view of the distal portion ofthe second embodiment of the dilator 200. FIG. 3B is a top view of theportion of the dilator 200 of FIG. 3; FIG. 3C is a cross-sectional viewof the portion of the dilator 200 of FIG. 3B taken through line 3C-3C;and FIG. 3D is a cross-sectional view of the portion of the dilator 200of FIG. 3C taken through line 3D-3D. The embodiment of FIGS. 3A-3D mayinclude components that resemble components of the embodiment of FIGS.2A-2D in some respects. For example, the embodiment of FIG. 3A includesa dilator 200 that may resemble the dilator 100 of FIG. 2A. It will beappreciated that all the illustrated embodiments have analogousfeatures. Accordingly, like features are designed with like referencenumerals, with leading digits added to increment each reference numeralby 100. (For instance, the dilator is designated “100” in FIG. 2A and ananalogous dilator is designated as “200” in FIG. 3A.) Relevantdisclosure set forth above regarding similarly identified features thusmay not be repeated hereafter. Moreover, specific features of thedilator shown in FIGS. 3A-3D may not be shown or identified by areference numeral in the drawings or specifically discussed in thewritten description that follows. However, such features may clearly bethe same, or substantially the same, as features depicted in otherembodiments and/or described with respect to such embodiments.Accordingly, the relevant descriptions of such features apply equally tothe features of the dilator of FIGS. 3A-3D. Any suitable combination ofthe features, and variations of the same, described with respect to thedilator illustrated in FIGS. 2A-2D, can be employed with the dilator ofFIGS. 3A-3D, and vice versa. This pattern of disclosure applies equallyto further embodiments depicted in subsequent figures and/or describedhereafter.

In the embodiment of FIGS. 3A-3D, the dilator 200 comprises a plug 214disposed in a lumen 208 proximal to at least a portion of a port 210. Insome embodiments, the plug 214 may be configured such that fluidcommunication is allowed or permitted between the proximal end and thedistal end 206 of the elongate member 202. In the illustrated embodimentof FIGS. 3C and 3D, the plug 214 does not completely occlude the lumen208 of the elongate member 202, in contrast to the plug 114 illustratedin FIG. 2D. The plug 214 comprises a substantially planar first surface220. The first surface 220, as illustrated, provides a recess in theplug 214 such that a gap 226, or fluid passage, is present between thefirst surface 220 of the plug 214 and a portion of the inside surface ofthe lumen 208. In some embodiments, a portion of an outside surface ofthe plug 214 may comprise one or more recesses such that one or moregaps 226 are formed or present between the portion of the outsidesurface of the plug 214 and a portion of the surface of the lumen 208.The gap 226 formed or created by the first planar surface 220 may befurther configured such that passage of a guide wire through the gap 226is not allowed or permitted. For example, the size of the gap 226 may besuch that the gap 226 is too small to allow or permit passage of a guidewire. The gap 226 may also be configured such that upon threading of adistal end of a guide wire through the lumen 208 and/or the port 210 ofthe dilator 200, the distal end of the guide wire does not get caught orstuck at or adjacent an entrance of the gap 226. In some embodiments, apractitioner may flush a dilator comprising one or more gaps 226 with asaline solution, a heparinized saline solution, water, and/or anotherphysiologically compatible sterile fluid prior to use, or during use, ofthe dilator.

As described above for the plug 114, the plug 214 may be coupled to theelongate member 202. For example, the plug 214 may be bonded or glued tothe elongate member 202. In other embodiments, the plug 214 may beintegrally formed with the elongate member 202. For example, the plug214 may be extruded and/or molded as an integral or intrinsic part ofthe elongate member 202.

FIGS. 4A-4D are various views of a distal portion of a third embodimentof a dilator 300. FIG. 4A is a perspective view of a distal portion ofthe third embodiment of the dilator 300. FIG. 4B is a top view of theportion of the dilator 300 of FIG. 4A; FIG. 4C is a cross-sectional viewof the portion of the dilator 300 of FIG. 4B taken through line 4C-4C;and FIG. 4D is a cross-sectional view of the portion of the dilator 300of FIG. 4C taken through line 4D-4D. In the embodiment of FIGS. 4A-4D,the illustrated dilator 300 comprises a plug 314 disposed in a lumen 308proximal to at least a portion of a port 310. Again, in someembodiments, such as illustrated in FIGS. 3C and 3D, a plug may beconfigured such that fluid communication is permitted between theproximal end and the distal end of the elongate member. Likewise, in theillustrated embodiment of FIG. 4C, the plug 314 does not block orcompletely occlude the lumen of the elongate member, in contrast to theplug 114 of FIGS. 2A-2D.

The illustrated plug 314 comprises a substantially planar first surface320 a and a substantially planar second surface 320 b (FIG. 4C). Both ofthe first surface 320 a and the second surface 320 b, as illustrated,provide recesses in the plug 314 such that gaps 326, or fluid passages,are formed or present between both of the first surface 320 a and thesecond surface 320 b of the plug 314 and portions of the inside surfaceof the lumen. In some embodiments, a portion or portions of an outsidesurface of the plug 314 may comprise a plurality of recesses such that aplurality of gaps 326 are formed or present between portions of theoutside surface of the plug 314 and portions of the surface of thelumen. The gaps 326 created by the first and second planar surfaces 320a, 320 b may be configured such that passage of a guide wire through thegaps 326 is not allowed or permitted. For example, the size of the gaps326 may be such that the gaps 326 are too small to allow or permitpassage of a guide wire. The gaps 326 created by the first and secondplanar surfaces 320 a, 320 b may also be configured such that uponthreading of a distal end of a guide wire through the lumen of thedilator and/or through the port, the guide wire does not get caught orstuck at or adjacent an entrance to one or more of the gaps.

As described above for other embodiments of the plug, the plug 314 maybe coupled to the elongate member 302 (FIGS. 4A, 4B, and 4D). Forexample, the plug 314 may be bonded or glued to the elongate member 302.In other embodiments, the plug 314 may be integrally formed with theelongate member 302. For example, the plug 314 may be extruded and/ormolded as an integral or intrinsic part of the elongate member 302.

FIGS. 5A-5D are various views of a distal portion of a fourth embodimentof a dilator 400. FIG. 5A is a perspective view of a distal portion ofthe fourth embodiment of the dilator 400. FIG. 5B is a top view of theportion of the dilator 400 of FIG. 5A; FIG. 5C is a cross-sectional viewof the portion of the dilator 400 of FIG. 5B taken through line 5C-5C;and FIG. 5D is a cross-sectional view of the portion of the dilator 400of FIG. 5C taken through line 5D-5D. In the embodiment of FIGS. 5A-5D,the dilator 400 comprises a plug 414 disposed in a lumen 408 proximal toat least a portion of a port 410. Again, in some embodiments, such asillustrated in FIGS. 3C and 3D, a plug may be configured such that fluidcommunication is permitted between the proximal end and the distal endof the elongate member. Likewise, in the illustrated embodiment of FIGS.5A-5D, the plug 414 does not completely occlude the lumen 408 of theelongate member 402, in contrast to the plug 114 of FIGS. 2A-2D. Theillustrated plug 414 is at least partially fluted on a portion of anoutside surface of the plug 414. As illustrated, the plurality of flutesprovide a plurality of recesses in the plug 414 such that a plurality ofgaps 426, or fluid passages, are formed or present between a portion ofthe outside surface of the plug 414 and a portion of the inside surfaceof the lumen 408. As illustrated, each gap 426 of the fluted plug 414 issubstantially semicircular. In other embodiments, the gaps 426 may beovoid, square, and/or triangular. Other shapes, or combinations ofshapes, of gaps 426 are also contemplated. The gaps 426 may beconfigured such that passage of a guide wire through the gaps 426 is notallowed or permitted. For example, the size of the gaps 426 may be suchthat the gaps 426 are too small to allow or permit passage of a guidewire. The gaps 426 may also be configured such that upon threading of aguide wire through the lumen 408 of the dilator 400 and/or through theport 410 of the dilator 400, the distal end of the guide wire does notget caught or stuck at or adjacent an entrance of one or more of thegaps 426. In other embodiments, the plug 414 may comprise a hole orholes passing through an interior of the plug 414 as opposed to a gap orgaps 426 passing along the outside surface of the plug 414.

As described above for other embodiments of the plug, the plug 414 maybe coupled to the elongate member 402. For example, the plug 414 may bebonded or glued to the elongate member 402. In other embodiments, theplug 414 may be integrally formed with the elongate member 402. Forexample, the plug 414 may be extruded and/or molded as an integral orintrinsic part of the elongate member 402.

FIGS. 6A-6D are various views of a distal portion of a fifth embodimentof a dilator 500. FIG. 6A is a perspective view of a distal portion ofthe fifth embodiment of the dilator 500. FIG. 6B is a top view of theportion of the dilator 500 of FIG. 6A; FIG. 6C is a cross-sectional viewof the portion of the dilator 500 of FIG. 6B taken through line 6C-6C;and FIG. 6D is a cross-sectional view of the portion of the dilator 500of FIG. 6C taken through line 6D-6D. In the embodiment of FIGS. 6A-6D,the dilator 500 comprises a plug 514 disposed in a lumen 508 proximal toat least a portion of a port 510. Again, in some embodiments, such asillustrated in FIGS. 3C and 3D, a plug may be configured such that fluidcommunication is permitted between the proximal end and the distal endof the elongate member. Likewise, in the embodiment of FIGS. 6A-6D, theplug 514 is configured to not completely occlude the lumen 508 of theelongate member 502, in contrast to the plug 114 of FIGS. 2A-2D. Theillustrated plug 514 comprises an elongate member 538 and a lumen 540,or fluid passage, disposed longitudinally within the elongate member 538(FIG. 6D). The plug 514 further comprises an opening 542 at or adjacenta proximal end of the plug 514. At a distal end of the plug 514 an uppersidewall of the plug 514 extends distally in relation to a lowersidewall of the plug 514. The extension of the upper sidewall of theplug 514 defines an angled surface extending from a surface of the lumen508 at or adjacent the port 510 to a surface of the lumen 508 oppositeof the port 510 forming a check valve 544. A distal end of the checkvalve 544 is not bonded or fixed to the elongate member 502. The checkvalve 544 may transition from a closed configuration, as illustrated inFIG. 6D, to an open configuration when, for example, a practitionerflushes a saline solution, a heparinized saline solution, water, and/oranother sterile physiologically compatible fluid through the lumen 508of the dilator 500. Fluid pressure distal of the plug 514 may open thecheck valve 544 while the check valve 544 may return to a closedconfiguration upon removal of a fluid pressure from the lumen 508.

As illustrated, the check valve 544 may also be configured such thatupon threading of a guide wire through the lumen 508 of the dilatorand/or through the port 510, the distal end of the guide wire does notget caught or stuck at or adjacent a junction of the plug 514 and theelongate member 502.

As described above for other embodiments of the plug, the plug 514 maybe coupled to the elongate member 502. For example, the plug 514 may bebonded or glued to the elongate member 502. In other embodiments, theplug 514 may be integrally formed with the elongate member 502. Forexample, the plug 514 may be extruded and/or molded as an integral orintrinsic part of the elongate member 502.

FIGS. 7A-7D are various views of a distal portion of a sixth embodimentof a dilator 600. FIG. 7A is a perspective view of the distal portion ofthe sixth embodiment of the dilator 600. FIG. 7B is a top view of theportion of the dilator 600 of FIG. 7A; FIG. 7C is a cross-sectional viewof the portion of the dilator 600 of FIG. 7B taken through line 7C-7C;and FIG. 7D is a cross-sectional view of the portion of the dilator 600of FIG. 7C taken through line 7D-7D. In the embodiment of FIGS. 7A-7D,the dilator 600 comprises a plug 614 disposed in a lumen 608 proximal toat least a portion of a port 610. Again, in some embodiments, such asillustrated in FIGS. 3C and 3D, a plug may be configured such that fluidcommunication is permitted between the proximal end and the distal endof the elongate member. Likewise, in the illustrated embodiment of FIGS.7C and 7D, the plug 614 does not completely occlude the lumen 608 of anelongate member 602, in contrast to the plug 114 of FIGS. 2A-2D. Theillustrated plug 614 comprises a substantially planar surface 620 alonga proximal portion of the plug 614. A distal end 616 of the plug 614defines an angled surface 618 extending from a surface of the lumenopposite of the port 610 to a position at or adjacent a proximal end 611of the port 610 and substantially in line with an outside surface of theelongate member 602 (FIG. 7D). Thus a substantially L-shaped gap 626, orfluid passage, is formed between the upper surface of the plug 614 andsurfaces of both of the lumen 602 and the port 610. As a proximal end ofthe angled surface 618 of the plug 614 is substantially in line with theoutside surface of the elongate member 602, the angled surface 618 maynot interfere with threading of a guide wire through the lumen 608and/or port 610 of the dilator 600. Stated another way, the plug 614 maybe configured such that the distal end of the guide wire does not getcaught or stuck as it passes into or out of the dilator 600.

As described above for other embodiments of the plug, the plug 614 maybe coupled to the elongate member 602. For example, the plug 614 may bebonded or glued to the elongate member 602. In other embodiments, theplug 614 may be integrally formed with the elongate member 602. Forexample, the plug 614 may be extruded and/or molded as an integral orintrinsic part of the elongate member 602.

FIG. 8 is a perspective view of an embodiment of a vascular accesssystem 730. The vascular access system 730 of FIG. 8 may be configuredfor use during a vascular procedure. Vascular procedures that may beperformed using the illustrated vascular access system 730 include, butare not limited to, atherectomy, aspiration, balloon catheterization,diagnostic catheterization, interventional catheterization, snarecapture/retrieval, and stent placement/removal. As shown in FIG. 8, thevascular access system 730, may comprise a catheter 732 and a dilator700 disposed within the catheter 732. The catheter 732 may comprise asheathless catheter—or a catheter configured for use without anintroducer sheath—such as a sheathless guiding catheter or a sheathlessguide. Catheters 732 that may be utilized in the vascular access system730 include, but are not limited to, balloon catheters, diagnosticcatheters, guiding catheters, and interventional catheters. In someembodiments, the dilator 700 may be disposable within the catheter 732.In certain embodiments, the dilator 700 may be axially disposable withinthe catheter 732. In some other embodiments, the dilator 700 may becouplable to the catheter 732. For example, the dilator 700 may becouplable to the catheter 732 at a hub portion 734.

In some embodiments, the dilator 700 may be stiffer, firmer, or moreresistant to bending than the catheter 732. Also, in certainembodiments, the dilator 700 may be longer than the catheter 732.

Referring again to the embodiment of FIG. 8, the illustrated dilator 700comprises an elongate member 702 comprising a proximal end 704 and adistal end 706. The dilator 700 may also comprise a lumen 708 disposedwithin at least a portion of the elongate member 702. As illustrated,the dilator 700 further comprises a port 710 disposed within a sidewallof the elongate member 702, wherein the port 710 may be in fluidcommunication with the lumen 708. In some embodiments, the port 710 maybe disposed transversely through the sidewall of the elongate member702. In some other embodiments, the lumen 708 may extend from theproximal end 704 to the distal end 706 of the elongate member 702.

The dilator 700 of the vascular access system 730 may also compriseother elements and/or features of the dilator 100, 200, 300, 400, 500,or 600 described above in connection with FIGS. 1-7D. For example, thedilator 700 may further comprise a plug, similar to plug 114, 214, 314,414, 514, or 614 illustrated in FIGS. 2A-7D, disposed in the lumen 708proximal to a portion of the port 710. Furthermore, a distal end of theplug may define an angled surface, similar to angled surface 118 of FIG.2D, extending from a surface of the lumen opposite of the port 710 to aposition at or adjacent to a proximal portion of the port 710.

Similar to the plug 114 illustrated in FIGS. 2A-2D, the plug of thedilator 700 may occlude the lumen 708 such that fluid communicationthrough the lumen 708 between the proximal end 704 and the distal end706 of the elongate member 702 is blocked, inhibited, or substantiallyinhibited at the plug. Alternatively, similar to the plugs 214, 314,414, 514, and 614 illustrated in FIGS. 3A-7D, the plug of the dilator700 may be configured such that fluid communication is allowed orpermitted between the proximal end 704 and the distal end 706 of theelongate member 702 via a gap and/or via a fluid passage. In someembodiments, a fluid passage may comprise a channel or passagewaythrough an inside portion of the plug.

FIG. 9 is a perspective view of a portion of the vascular access system730 of FIG. 8. In some embodiments, at least a portion of at least oneof the catheter 732 and/or the dilator 700 may be radiopaque. Forexample, the catheter 732 and/or the dilator 700 may comprise one ormore radiopaque bands 724. The one or more radiopaque bands 724 mayassist a practitioner in determining and/or visualizing the location orposition of the vascular access system 730 within a patient. Forexample, the practitioner may use a fluoroscope, or other imagingdevice, to visualize the location of the vascular access system 730within the vasculature of the patient by locating the positions of theone or more radiopaque bands 724. In some embodiments, the radiopaquebands may be positioned at predetermined points along a length of thevascular access system 730. For example, a radiopaque band 724 may bepositioned at or adjacent to the distal end 706 of the dilator 700. Inanother example, a radiopaque band 724 may be positioned at or adjacentto the distal end 736 of the catheter 732.

In some other embodiments, at least a portion of the vascular accesssystem 730 may be hydrophilic or otherwise lubricious. For example, aportion of an outside surface of both of the dilator 700 and thecatheter 732 may be hydrophilic such that the outside surface of thevascular access system 730 is lubricious, slippery, and/or smooth suchthat the vascular access system 730 may be disposed or moved through apercutaneous access site and/or a tortuous and/or narrow vasculature.

In other embodiments, a portion of an outside surface of one or both ofthe catheter 732 and the dilator 700 of the vascular access system 730extending from a proximal end 711 of a port 710 may comprise a recessconfigured to accommodate a portion of a guide wire. Such aconfiguration may aid in disposition or movement of the vascular systemin combination with a guide wire through a percutaneous access siteand/or through the vasculature.

In some embodiments, the catheter 732 and the dilator 700 may becouplable such that the dilator 700 may be partially disposed within thelumen of the catheter 732. In other embodiments, the catheter 732 andthe dilator 700 may be coupled at a hub portion 734 (FIG. 8).

Referring again to FIG. 9, the distal end 706 of the illustrated dilator700 extends distally relative to a distal end 736 of the catheter 732when the catheter 732 and the dilator 700 are in a coupledconfiguration. Also, the illustrated port 710 is disposed distallyrelative to the distal end 736 of the catheter 732 when the catheter 732and the dilator 700 are in a coupled configuration. Further, the distalend 736 of the illustrated catheter 732 is tapered such that there is asubstantially smooth transition between the distal end 736 of thecatheter 732 and the dilator 700. In other embodiments, the distal end706 of the illustrated dilator 700 is tapered. In certain embodiments, atapered portion of the dilator 700 may be longer than a tapered portionof the catheter 732. Other configurations of the catheter 732 and thedilator 700, such as catheters and dilators lacking tapered ends, arealso within the scope of this disclosure.

Methods of accessing a percutaneous site of a patient are alsodisclosed. The methods may facilitate completion of a procedure in fewersteps such that less equipment and/or fewer components may be utilized.In some instances, conducting fewer steps and/or utilizing fewercomponents may result in smaller access sites such that the methods mayresult in a lower incidence of arterial spasm and improved and/orquicker patient healing. In certain embodiments, methods of accessing apercutaneous access site may comprise introduction of a needle 850 intoa vessel 854 of a patient. FIG. 10A is a view showing introduction ofthe needle 850 into the vessel 854. In some embodiments, a practitioner852 may introduce the needle 850 into the vessel 854 of a patient. Inother embodiments, the vessel 854 may include, but is not limited to,the radial artery, the brachial artery, or the femoral artery. Forexample, the dilators and/or vascular access systems of the presentdisclosure may be adapted for use in accessing the femoral artery, incontrast to accessing the radial artery, by the use of a larger needle,dilator, catheter, guide wire, and/or other components.

In some embodiments, the methods may further comprise introducing afirst guide wire 856 into the vessel 854 via the introduced needle 850.FIG. 10B is a view showing introduction of the first guide wire 856 intothe vessel 854 through a lumen 851 of the needle 850. In certainembodiments, the practitioner 852 may introduce the first guide wire 856into the vessel 854 through the lumen 851 of the needle 850. In otherembodiments, the practitioner 852 may introduce more than one guide wireinto the vessel 854, for example, two guide wires, three guide wires,and so on. The arrows, as shown in FIG. 10B, illustrate the introductionof the first guide wire 856 into the vessel 854 via the needle 850.Different sizes of guide wires may be used in the disclosed method. Insome embodiments, a 0.018 inch diameter guide wire 856 may be used. Inother embodiments, 0.021 inch, 0.025 inch, 0.032 inch, 0.035 inch, or0.038 inch diameter guide wires 856 may be used. In some otherembodiments, guide wires 856 of other diameters may be used.

The methods may also further comprise extraction of the needle 850 fromthe vessel 854. FIG. 10C is a view showing removal of the needle 850from the vessel 854. In some embodiments, the practitioner 852 mayremove the needle 850 from the vessel 854 while leaving the first guidewire 856 disposed within the vessel 854. The arrows, as shown in FIG.100, illustrate the removal of the needle 850 from the vessel 854.

In some embodiments, the methods may further comprise introduction ofthe first guide wire 856 into a dilator 800. FIG. 10D is a view showingthreading of the first guide wire 856 through an opening 801 at a distalend 806 of the dilator 800, wherein the dilator 800 is disposed within acatheter 832. In certain embodiments, the practitioner 852 may insert aproximal end 858 of the first guide wire 856 through the opening 801 ator adjacent to the distal end 806 of the dilator 800, as indicated bythe arrows. As illustrated, a portion of the dilator 800 is disposedwithin the catheter 832. In certain embodiments, a portion of thedilator 800 may be axially disposed within the catheter 832. In otherembodiments, the dilator 800 may not be disposed within a catheter 832.In some embodiments, the size of the catheter 832 may be 5 F (Frenchsize). In some other embodiments, the catheter 832 may be 6 F, 7 F, or 8F. Other sizes of catheters 832 are also contemplated.

The methods may further comprise introducing the dilator 800 and/or thecatheter 832 into the vessel 854. FIG. 10E is a view showing dispositionof the dilator 800 and the catheter 832 into the vessel 854. In someembodiments, the practitioner 852 may introduce both of the dilator 800and the catheter 832 into the vessel 854 of the patient along at least aportion of the first guide wire 856. In other embodiments, thepractitioner may flush the dilator 800 and/or catheter 832 with salinesolution, heparinized saline solution, water, and/or anotherphysiologically compatible sterile fluid prior to introduction of thedilator 800 and/or catheter into the vessel 854 of the patient.

In certain embodiments, the methods may further comprise extracting thefirst guide wire 856 and/or the dilator 800 from the vessel 854. FIG.10F is a view showing removal of the first guide wire 856 from thevessel 854. In some embodiments, the practitioner 852 may remove thefirst guide wire 856 from both of the dilator 800 and the vessel 854.FIG. 10G is a view showing removal of the dilator 800 from the vessel854. In other embodiments, the practitioner 852 may remove the dilator800 from both of the vessel 854 and the catheter 832, as indicated bythe arrows. The dilator 800 may be decoupled from the catheter 832 at ahub portion 834. In some other embodiments, the dilator 800 may not becoupled to the catheter 832 at a hub portion 834.

In some embodiments, the methods may comprise introduction of a secondguide wire 857 through the catheter 832. FIG. 10H is a view showingintroduction of the second guide wire 857 into or through the catheter832. The practitioner 852 may displace a distal end 859 of the secondguide wire 857 through the vessel 854 to a position at or adjacent atherapy site 860. The catheter 832 may then be advanced or threadedalong the second guide wire 857 such that a distal end 836 of thecatheter 832 is disposed at or adjacent the therapy site 860.

The methods may further comprise placement of the catheter 832 at atherapy site 860 without threading or displacing the catheter 832 alonga guide wire, such as the second guide wire 857 illustrated in FIG. 10H.FIG. 10I is a view showing disposition and visualization of thedisposition of a distal end 836 of the catheter 832 at a therapy site860. The therapy site 860 may be the site, for example, of an embolus,an occlusion, a plaque, or another feature. In some embodiments, thepractitioner 852 may displace the catheter 832 through the vessel 854such that a distal end 836 of the catheter 832 is disposed at oradjacent to the therapy site 860 within the patient. An imaging device862, such as a fluoroscope, may be used to visualize the placement orpositioning of the distal end 836 of the catheter 832.

In certain embodiments, the methods may further comprise conducting avascular procedure. FIG. 10J is a view showing performance andvisualization of the performance of a vascular procedure at the therapysite 860. In some embodiments, the practitioner 852 may displace amedical device 864 through a lumen of the catheter 832 such that themedical device 864 is disposed at or adjacent to the therapy site 860within the vessel 854 of the patient. The practitioner 852 may thenperform a vascular procedure at or adjacent to the therapy site 860within the vessel 854 of the patient. An imaging device 862, such as afluoroscope, may be used to visualize the performance of the vascularprocedure at the therapy site 860. The medical device 864 may include,but is not limited to, an atherectomy device, an aspirator, a ballooncatheter (as illustrated in FIG. 10J), a diagnostic catheter, a guidingcatheter, an interventional catheter, a snare, or a stent.

In other embodiments, the methods may further comprise extraction of thecatheter 832 from the patient. FIG. 10K is a view showing removal of thecatheter 832 from the vessel 854. In some embodiments, the practitioner852 may remove the medical device 864 and/or the catheter 832 from thevessel 854 of the patient as indicated by the dashed arrows.

EXEMPLARY EMBODIMENTS

The following embodiments are illustrative and exemplary and not meantas a limitation of the scope of the present disclosure in any way.

I. Dilators for Percutaneous Access

In one embodiment, a dilator configured for percutaneous accesscomprises: (1) an elongate member comprising a proximal end and a distalend; (2) a lumen disposed within at least a portion of the elongatemember; and (3) a port disposed in a sidewall of the elongate member,wherein the port is in fluid communication with the lumen.

The lumen may extend from the proximal end to the distal end of theelongate member.

The dilator may further comprise a plug disposed in the lumen proximalto a portion of the port.

A distal end of the plug may define an angled surface extending from asurface of the lumen opposite of the port to a position at or adjacent aproximal portion of the port.

The angled surface may be configured to direct a guide wire extendingfrom the distal end of the elongate member through the port.

The plug may occlude the lumen such that fluid communication through thelumen between the proximal end and the distal end of the elongate memberis inhibited at the plug.

The plug may be configured such that fluid communication is permittedbetween the proximal end and the distal end of the elongate member.

The plug may comprise a fluid passage.

The plug may comprise a check valve.

The plug may be coupled to the elongate member.

The lumen may extend from the distal end of the elongate member to theport.

The lumen may be configured to direct a guide wire extending from thedistal end of the elongate member through the port.

A portion of the elongate member may be radiopaque.

A portion of the distal end of the elongate member may be tapered.

A portion of the elongate member may be hydrophilic.

A portion of an outside surface of the elongate member extending from aproximal end of the port may comprise a recess configured to accommodatea portion of a guide wire.

II. Apparatuses for Percutaneous Access

In one embodiment, an apparatus configured for a percutaneous accesssite, comprises: an elongate member configured for passage of fluidthrough at least a portion of the elongate member; wherein the elongatemember is configured for passage of a guide wire through only a portionof the elongate member; and wherein the guide wire is displaceable alonga portion of the elongate member through a first opening of the elongatemember and wherein the elongate member comprises an angled guidingsurface configured to direct the guide wire out a second opening of theelongate member.

The elongate member may be configured for passage of fluid alongsubstantially an entire length of the elongate member.

The second opening may be disposed in a sidewall of the elongate member.

III. Vascular Access Systems

In one embodiment, a vascular access system configured for use during avascular procedure comprises: (1) a catheter; and (2) a dilatordisposable within the catheter, wherein the dilator comprises: (a) anelongate member comprising a proximal end and a distal end, (b) a lumendisposed within at least a portion of the elongate member, and (c) aport disposed in a sidewall of the elongate member, wherein the port isin fluid communication with the lumen.

The lumen may extend from the proximal end to the distal end of theelongate member.

The dilator may further comprise a plug disposed in the lumen proximalto a portion of the port.

A distal end of the plug may define an angled surface extending from asurface of the lumen opposite of the port to a position at or adjacent aproximal portion of the port.

The plug may occlude the lumen such that fluid communication through thelumen between the proximal end and the distal end of the elongate memberis inhibited at the plug.

The plug may be configured such that fluid communication is permittedbetween the proximal end and the distal end of the elongate member.

The plug may comprise a fluid passage.

The system may be configured such that a guide wire cannot pass throughthe fluid passage.

A portion of at least one of the catheter or the dilator may beradiopaque.

A portion of one or both of the catheter and the dilator may behydrophilic.

A portion of an outside surface of one or both of the catheter and thedilator extending from a proximal end of the port may comprise a recessconfigured to accommodate a portion of a guide wire.

The catheter and the dilator may be couplable such that the dilator ispartially disposed within a lumen of the catheter.

A distal end of the dilator may extend distally relative to a distal endof the catheter when the catheter and the dilator are coupled.

The port may be disposed distally relative to the distal end of thecatheter when the dilator and the catheter are coupled.

The distal end of the catheter may be tapered such that there is asmooth transition between the distal end of the catheter and thedilator, and wherein the distal end of the dilator is tapered.

A tapered portion of the dilator may be longer than a tapered portion ofthe catheter.

The dilator may be stiffer than the catheter.

The dilator may be longer than the catheter.

IV. Method of Accessing Percutaneous Sites

In one embodiment, a method of accessing a percutaneous site of apatient, comprises: (1) inserting a proximal end of a first guide wirethrough an opening at or adjacent a distal end of a dilator, wherein aportion of the dilator is disposed within a catheter; (2) threading thefirst guide wire through both of a portion of a lumen of the dilator anda port disposed in a sidewall of the dilator; and (3) introducing boththe dilator and the catheter into a vessel of the patient along aportion of the first guide wire.

The method may further comprise: (1) introducing a needle into thevessel; (2) introducing the first guide wire into the vessel through alumen of the needle; and (3) removing the needle from the vessel priorto inserting the proximal end of the first guide wire through theopening at or adjacent the distal end of the dilator.

The method may further comprise: (1) removing the first guide wire andthe dilator from the vessel; and (2) displacing the catheter through thevessel such that a distal end of the catheter is disposed at or adjacenta therapy site within the patient subsequent to introducing both thedilator and the catheter into the vessel along a portion of the firstguide wire.

The method may further comprise: (1) removing the first guide wire andthe dilator from the vessel; (2) introducing a second guide wire throughthe catheter; (3) disposing a distal end of the second guide wire at oradjacent a therapy site; and (4) advancing the catheter along the secondguide wire such that a distal end of the catheter is disposed at oradjacent the therapy site.

The method may further comprise displacing a medical device through thecatheter such that the medical device is disposed at or adjacent atherapy site within the vessel.

The method may further comprise performing a vascular procedure at oradjacent the therapy site within the vessel.

The medical device may be selected from at least one of: an atherectomydevice, an aspirator, a balloon catheter, a diagnostic catheter, aguiding catheter, an interventional catheter, a snare, or a stent.

The examples and embodiments disclosed herein are to be construed asmerely illustrative and exemplary, and not a limitation of the scope ofthe present disclosure in any way. It will be apparent to those havingskill in the art with the aid of the present disclosure that changes maybe made to the details of the above-described embodiments withoutdeparting from the underlying principles of the disclosure herein.Moreover, the order of the steps or actions of the methods disclosedherein may be changed by those skilled in the art without departing fromthe scope of the present disclosure. In other words, unless a specificorder of steps or actions is required for proper operation of theembodiment, the order or use of specific steps or actions may bemodified. It is intended that the scope of the invention be defined bythe claims appended hereto and their equivalents.

1. A dilator configured for percutaneous access, the dilator comprising:an elongate member comprising a proximal end and a distal end; a lumendisposed within at least a portion of the elongate member; and a portdisposed in a sidewall of the elongate member, wherein the port is influid communication with the lumen.
 2. The dilator of claim 1, whereinthe lumen extends from the proximal end to the distal end of theelongate member.
 3. The dilator of claim 2, further comprising a plugdisposed in the lumen proximal to a portion of the port.
 4. The dilatorof claim 3, wherein a distal end of the plug defines an angled surfaceextending from a surface of the lumen opposite of the port to a positionat or adjacent a proximal portion of the port.
 5. The dilator of claim4, wherein the angled surface is configured to direct a guide wireextending from the distal end of the elongate member through the port.6. The dilator of claim 4, wherein the plug occludes the lumen such thatfluid communication through the lumen between the proximal end and thedistal end of the elongate member is inhibited at the plug.
 7. Thedilator of claim 4, wherein the plug is configured such that fluidcommunication is permitted between the proximal end and the distal endof the elongate member.
 8. The dilator of claim 7, wherein the plugcomprises a fluid passage.
 9. The dilator of claim 8, wherein the plugcomprises a check valve.
 10. The dilator of claim 1, wherein the lumenextends from the distal end of the elongate member to the port.
 11. Thedilator of claim 10, wherein the lumen is configured to direct a guidewire extending from the distal end of the elongate member through theport.
 12. The dilator of claim 1, wherein a portion of the elongatemember is hydrophilic.
 13. The dilator of claim 1, wherein a portion ofan outside surface of the elongate member extending from a proximal endof the port comprises a recess configured to accommodate a portion of aguide wire.
 14. An apparatus configured for a percutaneous access site,comprising: an elongate member configured for passage of fluid throughat least a portion of the elongate member; wherein the elongate memberis configured for passage of a guide wire through only a portion of theelongate member; and wherein the guide wire is displaceable along aportion of the elongate member through a first opening of the elongatemember and wherein the elongate member comprises an angled guidingsurface configured to direct the guide wire out a second opening of theelongate member.
 15. The apparatus of claim 14, wherein the elongatemember is configured for passage of fluid along substantially an entirelength of the elongate member.
 16. The apparatus of claim 14, whereinthe second opening is disposed in a sidewall of the elongate member. 17.A method of accessing a percutaneous site of a patient, comprising:inserting a proximal end of a first guide wire through an opening at oradjacent a distal end of a dilator, wherein a portion of the dilator isdisposed within a catheter; threading the first guide wire through bothof a portion of a lumen of the dilator and a port disposed in a sidewallof the dilator; and introducing both the dilator and the catheter into avessel of the patient along a portion of the first guide wire.
 18. Themethod of claim 17, further comprising: removing the first guide wireand the dilator from the vessel; and displacing the catheter through thevessel such that a distal end of the catheter is disposed at or adjacenta therapy site within the patient subsequent to introducing both thedilator and the catheter into the vessel along a portion of the firstguide wire.
 19. The method of claim 17, further comprising: displacing amedical device through the catheter such that the medical device isdisposed at or adjacent a therapy site within the vessel.
 20. The methodof claim 19, wherein the medical device is selected from at least oneof: an atherectomy device, an aspirator, a balloon catheter, adiagnostic catheter, a guiding catheter, an interventional catheter, asnare, or a stent.